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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K033394
Device Name CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
Applicant
Cordis Corp.
7 Powderhorn Dr.
Warren,  NJ  07059
Applicant Contact KAREN WILK
Correspondent
Cordis Corp.
7 Powderhorn Dr.
Warren,  NJ  07059
Correspondent Contact KAREN WILK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/23/2003
Decision Date 12/22/2003
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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